Indiana residents with degenerative disc disease are invited to learn more about participating in this ongoing spinal fusion study
INDIANAPOLIS—OrthoIndy continues to lead the way in orthopedic and spine care advancements by enrolling and treating the first patient worldwide with a new spinal fusion implant using an innovative spine surgery approach. Several months after becoming the first orthopedic practice globally to treat patients in the OASIS clinical trial using the transforaminal interbody fusion (TLIF) technique, OrthoIndy has now successfully performed the first spine surgery with this innovative product using the anterior lumbar interbody fusion (ALIF) approach.
OsteoAdapt SP is a cutting-edge spinal fusion implant developed by Theradaptive, Inc, to address the challenges of traditional bone grafts and artificial implants used in spinal fusion surgeries. In December, Theradaptive announced that OsteoAdapt SP received FDA approval to study the product in conjunction with the ALIF technique. The first patient was treated at OrthoIndy shortly thereafter by Dr. M. Craig McMains, marking another significant milestone in the field of spine care.
“This patient experienced noticeably less pain upon leaving the hospital than when he arrived,” said Dr. McMains. “Offering innovative solutions like OsteoAdapt SP with the ALIF approach reinforces OrthoIndy’s commitment to advancing spine care and improving patient outcomes.”
Significant Differences in TLIF and ALIF Approaches
The TLIF and ALIF approaches differ significantly in their surgical techniques. In the TLIF approach, the patient lies on their stomach while the surgeon inserts the implant into a small cage placed within the spine’s disc space. Additionally, bone recovered from the patient during surgery aids in the healing process.
In contrast, the ALIF technique involves accessing the spine through the abdomen while the patient lies on their back. This approach minimizes trauma to the muscles, reduces blood loss, and enables the use of a larger implant cage for enhanced stability and improved fusion outcomes. Typically, bone is not recovered from the patient using this method, so there is a greater demand for a high-performing synthetic bone graft like OsteoAdapt SP.
OsteoAdapt SP contains a specially engineered protein designed to encourage bone growth while eliminating the risks of disease transmission that can be associated with donor bone grafts. It may also reduce or prevent chronic pain some patients experience with bone grafts recovered from their own bodies.
“Conducting a clinical trial with ALIF allows us to address the unique demands of this approach and help a broader range of patients,” said Dr. Luis Alvarez, CEO of Theradaptive. “We’re proud to partner with OrthoIndy to deliver advanced therapeutic solutions that redefine spinal fusion care.”
Dr. David Schwartz, another spine surgeon at OrthoIndy, performed the trial’s first TLIF procedure in 2024. “Theradaptive’s technology represents a significant advancement in applying bone-forming proteins,” said Dr. Schwartz. “We’re honored to be part of this critical study, which has the potential to reshape spinal fusion outcomes worldwide.”
Seeking Additional Trial Participants
As leaders in the Phase I/II OASIS trial, Drs. McMains and Schwartz are actively recruiting additional patients with degenerative disc disease to participate in this ongoing study. The trial includes comprehensive monitoring and advanced imaging to ensure safety and track progress.
OrthoIndy invites Indiana residents with degenerative spinal conditions to learn more about this promising alternative to traditional spinal fusion. For more information or to schedule an assessment with Drs. Schwartz or McMains, please call OrthoIndy at 317.802.2000.
Media Contact: Brandon Smith, Chief Development Officer at OrthoIndy, P: 317.802.2439, E: [email protected]
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About OsteoAdapt SP
OsteoAdapt SP is an investigational therapeutic for patients with degenerative disc disease, a condition characterized by the deterioration of spinal joints, which leads to pain and dysfunction. OsteoAdapt SP contains a next-generation protein called AMP2, which retains the powerful bone formation properties of recombinant human bone morphogenetic protein-2 (rhBMP-2) but without its off-target effects. Preclinical studies suggest that OsteoAdapt SP may offer improved safety and effectiveness compared to spinal fusion grafts. OsteoAdapt is also being developed for dental, orthopedic, sports medicine and veterinary applications.
CAUTION – OsteoAdapt SP is an investigational device. Limited by Federal law to investigational use or clinical trial use.
About Theradaptive
Theradaptive is a venture-backed biopharmaceutical and medical device company based in Frederick, Maryland. The company aims to leverage its therapeutic delivery platform to deliver biologics to targeted areas in the body with high levels of precision and persistence, addressing unmet medical needs. Theradaptive’s innovative platform is enabling the development of new therapeutics in spine, orthopedics and soft tissue repair, as well as targeted immuno-oncology. For more information on Theradaptive and its clinical development program, visit www.theradaptive.com and follow the company on LinkedIn.
About OrthoIndy
OrthoIndy is one of the most highly respected orthopedic practices in the country. With over 90 physicians providing care to Indiana residents, OrthoIndy provides leading-edge bone, joint, spine and muscle care. Recognized with numerous national and statewide honors from Healthgrades, OrthoIndy has been ranked number one in Indiana for joint replacement for the third year in a row. OrthoIndy is the official orthopedic provider for the Indiana Pacers, Indiana Fever and serves as the preferred orthopedic provider for employees of both the State of Indiana and Indianapolis Public Schools. For more information on OrthoIndy, please call 317.802.2000 or visit us at OrthoIndy.com.